ENDOSURE

ENDOSURE

Open  for investment

About this raise: ENDOSURE, with a valuation of $15 million, is raising funds on StartEngine. The company aims to transform endometriosis diagnosis with its AI-driven, non-invasive ENDOSURE Test. ENDOSURE combines the Tricorder-3L device with its proprietary EKG-type consumable to detect endometriosis across all stages of the disease. The test detects all four stages of the disease with 99% accuracy and has distribution agreements in place in the UK, Gulf States, Brazil, Israel, and Canada. Mark David Noar and Carlos Jose Babini founded ENDOSURE in July 2022. The current crowdfunding campaign has a minimum target of $123,997.50 and a maximum target of $1.23 million. The campaign proceeds will be used for company employment, inventory, sales and marketing training, regulatory expenses, and working capital.

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Investment Overview

Committed this round: $46,944

Deal Terms

Total Commitments ($USD)

Platform
StartEngine
Start Date
12/02/2024
Close Date
03/03/2025
Min. Goal
$123,998
Max. Goal
$1,234,999
Min. Investment

$499

Security Type

Equity - Common

Series

Seed

SEC Filing Type

RegCF    Open SEC Filing

Price Per Share

$3.75

Pre-Money Valuation

$15,000,000

Company & Team

Company

Year Founded
2022
Industry
Healthcare & Pharmaceuticals
Tech Sector
HealthTech
Distribution Model
B2B2C
Margin
High
Capital Intensity
Low
Location
Sparks Glencoe, Maryland
Business Type
Growth
Company Website
Visit Website

Team

Employees
8
Prior Founder Exits?
No
Founder Name
Mark Noar
Title
Board Member, Inventor, Chief Regulatory/Medical Officer
Founder Name
Carlos Babini
Title
Board Member, CEO

Financials

as of July 1, 2024
 Revenue
$224,716
 Monthly Burn
$40,000
 Runway
0.4 months
Gross Margin
90%

Summary Profit and Loss Statement

FY 2023 FY 2022

Revenue

$224,716

$14,850

COGS

$22,999

$5,400

Tax

$0

$0

 

 

Net Income

$-208,368

$-171,953

Summary Balance Sheet

FY 2023 FY 2022

Cash

$2,652

$23,277

Accounts Receivable

$1,376

$0

Total Assets

$42,473

$23,277

Short-Term Debt

$167,774

$23,166

Long-Term Debt

$422,394

$194,830

Total Liabilities

$590,168

$217,996

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Synopsis

ENDOSURE is a healthcare company focused on improving the diagnosis of endometriosis. The company offers a non-invasive test known as the ENDOSURE Test, which aims to accurately detect endometriosis across all stages of the disease. ENDOSURE operates using a "razor and razorblade" model, combining the Tricorder-3L device with proprietary EKG-type consumable leads. This model is designed to serve healthcare providers and potentially patients who are seeking more efficient and less invasive diagnostic methods.

Endometriosis is a prevalent condition affecting millions of women worldwide, characterized by the presence of tissue similar to the lining inside the uterus growing outside it. This can lead to severe pain and fertility issues. Traditional diagnostic methods often involve invasive procedures, which can be costly and time-consuming. The ENDOSURE Test addresses this problem by providing a 30-minute, non-invasive diagnostic tool with high accuracy.

In everyday scenarios, women experiencing unexplained pelvic pain or fertility challenges might face lengthy and invasive testing processes. ENDOSURE's solution offers a more accessible and less intrusive alternative, potentially reducing the time and discomfort associated with traditional diagnostic methods. This approach could streamline the diagnostic journey for patients and healthcare providers, making it a practical option for those seeking clarity and diagnosis in a more efficient manner.

Next Section: Price

Price

ENDOSURE is offering common equity to investors in its current fundraising round. The company is valued at $15 million with a price per share set at $3.75. This structure allows investors to directly own a portion of the company, which can be beneficial in terms of voting rights and potential dividends. However, it also means that investors may face more significant risks compared to preferred equity, which often comes with additional protective provisions.

For investors seeking a substantial return, achieving a 10X return on an investment in ENDOSURE would require the company to reach a valuation of approximately $150 million (not accounting for future dilution). This could be accomplished through significant revenue growth, successful market penetration, and potentially strategic partnerships or acquisitions. The current revenue multiple for ENDOSURE stands at 66.75x, which is very high. This suggests that the current valuation may be optimistic, potentially reflecting expectations of strong future growth or market leadership in the endometriosis diagnostics sector.

Investors should be aware that while high revenue multiples may indicate strong market interest, they can also suggest that the deal terms may not be favorable, particularly if the company's growth does not meet expectations. As with any startup investment, there is inherent risk, and returns are not guaranteed. Therefore, careful consideration of the company's potential to scale and achieve market milestones is crucial for evaluating the investment opportunity.

Next Section: Market

Market

The endometriosis diagnostic market is propelled by several compelling factors that make it an attractive investment opportunity. At the forefront is the substantial and growing disease burden, with approximately 190 million reproductive-age females worldwide affected by endometriosis, representing about 10% of the female population. This prevalence is coupled with an increasing awareness of women's health issues, driven by both patient education initiatives and broader societal focus on female-specific medical concerns. The current diagnostic landscape is characterized by delayed detection, often resulting in years of suffering before proper diagnosis, which creates a pressing need for improved early diagnostic solutions. This gap in the market is further accentuated by the robust product pipeline in the endometriosis space, with ongoing research and development efforts aimed at creating more effective treatment options. These drivers collectively contribute to a dynamic market environment ripe for innovation and investment, particularly in the realm of non-invasive, accurate, and timely diagnostic tools.

Next Section: Team

Team

ENDOSURE's leadership team is composed of experienced professionals with significant backgrounds in the healthcare sector. Mark Noar serves as the Board Member, Inventor, and Chief Regulatory/Medical Officer. With 21 years of industry experience, his expertise in medical technology and regulatory affairs is crucial for navigating the complex approval processes that the company faces. His role is vital in ensuring that ENDOSURE's products meet stringent regulatory standards, which is essential for market entry and expansion.

Carlos Babini, the CEO and Board Member, brings 25 years of relevant industry experience. His leadership is focused on strategic growth and operational management, aligning with ENDOSURE's objectives to scale its operations and establish a strong market presence. Babini's managerial skills are instrumental in driving the company's business development and partnership strategies.

The team, consisting of eight members, appears well-rounded in terms of regulatory and operational expertise. However, there may be a need to enhance capabilities in marketing and sales to effectively promote the ENDOSURE Test and achieve broader market penetration. Addressing these potential gaps could be critical for reaching future milestones and maximizing the company's growth potential.

Next Section: Differentiation

Differentiation

ENDOSURE operates in the endometriosis diagnostic market, where it faces competition from companies like AbbVie and Myovant Sciences. AbbVie, a large pharmaceutical company, offers Orilissa, a treatment for endometriosis pain, though not a diagnostic tool. This positions AbbVie more as a complementary player rather than a direct competitor. Myovant Sciences, another competitor, focuses on treatments, specifically with its product Relugolix, targeting similar demographics but not directly competing in diagnostics.

Compared to these companies, ENDOSURE is smaller in size but offers a unique product with its non-invasive diagnostic test. The product quality is highlighted by its reported 99% accuracy, which sets it apart from traditional diagnostic methods. Pricing details for ENDOSURE's test are not specified, but its approach may offer cost advantages over surgical diagnostics.

The primary customer demographic for ENDOSURE's product includes healthcare providers, such as gynecologists and clinics, who seek efficient diagnostic tools for their patients. Additionally, women experiencing symptoms of endometriosis form a secondary target group, as they may directly benefit from a more accessible diagnostic option.

Next Section: Performance

Performance

ENDOSURE's financial performance reflects its early-stage status in the healthcare industry. The company reported annual revenue of $224,716 for the most recent fiscal year, with no growth from the previous year. This indicates a need for strategies to enhance revenue generation as the company continues to develop and market its product.

The company's financial management is critical, given its cash position and expenditure levels. ENDOSURE's most recent monthly burn is $40k, while cash on hand stands at $16k. This financial situation highlights the necessity for careful cash flow management and potentially securing additional funding to sustain operations and support growth initiatives.

Despite the challenges, ENDOSURE has managed to establish distribution agreements in several key markets, including the UK, Gulf States, Brazil, Israel, and Canada. These agreements could provide a foundation for future revenue growth, contingent upon successful regulatory approvals and market penetration.

Next Section: Risk

Risk

ENDOSURE's high revenue multiple of 66.75x is a risk indicator, which may be ambitious relative to its current financial performance. If the company's growth does not align with these expectations, the valuation could adjust unfavorably, impacting investor returns.

The company's financial runway is also concerning. Cash and cash equivalents are reported at $16k, coupled with a monthly burn rate of $40k. This implies a limited financial runway, which could pressure the company to secure additional funding sooner than anticipated, potentially diluting existing shareholders.

Finally, the company's need for extensive regulatory approvals, such as CE MDR certification for Europe and ongoing FDA approval processes, poses a risk. These procedures can be lengthy and uncertain, potentially delaying market entry and revenue generation. Any setbacks in obtaining these approvals could impact the company's ability to execute its business plan effectively.

Next Section: Bullish Outlook

Bullish Outlook

ENDOSURE's existing distribution agreements in key international markets, such as the UK, Gulf States, Brazil, Israel, and Canada, signify a readiness to expand beyond the U.S. This geographic expansion could significantly enhance revenue streams and market presence. Additionally, the company's focus on AI-driven diagnostic solutions aligns with emerging trends in healthcare technology, offering potential for further product enhancements and market differentiation.

While current financial metrics indicate challenges, the company's valuation of $15 million, when compared to industry benchmarks, suggests potential for investor returns, especially if operational milestones are achieved. The strategic partnerships and product scalability offer pathways for financial improvement, contingent on successful execution.

Overall, ENDOSURE's positioning within a growing market, combined with its unique product offering and experienced team, provides a foundation for optimism. If the company can capitalize on these growth drivers and overcome regulatory and financial hurdles, it holds the potential for significant advancement and market impact.

Next Section: Bearish Outlook

Bearish Outlook

Several factors contribute to a bearish outlook for ENDOSURE. The company faces significant market challenges, primarily deriving from the competitive landscape and the need for regulatory approvals. The high revenue multiple of 66.75x suggests that the company's current valuation may be optimistic, especially in a market that demands rigorous regulatory clearances. Any delays in obtaining these approvals could significantly impact market entry and revenue growth.

From a competitive standpoint, ENDOSURE's product, while non-invasive and accurate, must contend with established diagnostic methods and potential new entrants offering similar solutions. The absence of a clear advantage in speed or cost over competitors could limit its market penetration and adoption by healthcare providers.

Concerns also arise regarding the company's financial situation. With a cash reserve of $16k and a monthly burn rate of $40k, ENDOSURE's financial runway is short. This precarious financial position might necessitate additional funding rounds, potentially diluting existing shareholders and impacting investor returns. Moreover, the absence of significant revenue growth underscores challenges in scaling operations and achieving financial sustainability.

Next Section: Executive Summary

Executive Summary

ENDOSURE is a healthcare company focused on providing a non-invasive diagnostic test for endometriosis. Its core customers include healthcare providers and potentially patients seeking efficient diagnostic solutions. The company is offering common equity with a valuation of $15 million and a share price of $3.75. Despite a lack of revenue growth, the company has established distribution agreements in several international markets, indicating potential for future expansion.

In terms of market positioning, ENDOSURE targets the growing U.S. endometriosis market, valued at approximately $456 million with a 12.6% growth rate. Its product stands out due to its non-invasive nature and high accuracy, setting it apart from traditional diagnostic methods. This broad appeal positions the company to capture a significant portion of the market, provided it successfully navigates regulatory hurdles.

On the bullish side, ENDOSURE benefits from a strong market demand for improved diagnostic tools and a unique product offering that could disrupt traditional methods. However, the bearish perspective highlights financial constraints and regulatory challenges that could hinder progress. These factors must be balanced to assess the investment's potential.

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Company Funding & Growth

Funding history

Total Prior Capital Raised
$100,000
VC Backed?
No
Close Date Platform Valuation Total Raised Security Type Status Reg Type
03/03/2025 StartEngine $15,000,000 $46,944 Equity - Common Active RegCF
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ENDOSURE on StartEngine 2024
Platform: StartEngine
Security Type: Equity - Common
Valuation: $15,000,000
Price per Share: $3.75

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